A laboratory information management system ( LIMS ), sometimes referred to as laboratory information systems ( LIS ) or < b> laboratory management system ( LMS ), is a software-based solution with features that support modern laboratory operations. Key features include - but are not limited to - workflow and data tracking support, flexible architecture, and data exchange interface, which fully "supports its use in regulated environments". The features and uses of LIMS have evolved over the years from simple sample tracking to enterprise resource planning tools that manage various aspects of laboratory informatics.
The LIMS definition is somewhat controversial: LIMS is dynamic because laboratory requirements are growing rapidly and different laboratories often have different needs. Therefore, the working definition of LIMS ultimately depends on the interpretation by the individual or group involved.
Historically, LIMS, LIS, and development process execution systems (PDES) have all the same functions. The term "LIMS" tends to refer to informatics systems targeted for environmental, research, or commercial analyzes such as pharmaceutical or petrochemical work. "LIS" tends to refer to laboratory informatics systems in forensic and clinical markets, which often require specialized case management tools. "PDES" is generally applied to a wider range, including, for example, virtual manufacturing techniques, while not necessarily being integrated with laboratory equipment.
More recently, the LIMS function has spread further beyond its original goal of sample management. data management testing, data mining, data analysis, and integration of electronic laboratory books (ELN) have been added to many LIMS, allowing the realization of translational drugs entirely within a single software solution. In addition, the differences between LIMS and LIS have blurred, as many LIMS now also fully support full comprehensive case-centric clinical data.
Video Laboratory information management system
Histori
Until the late 1970s, the management of laboratory samples and associated analysis and reporting were time-consuming manual processes that were often filled with transcription errors. This gives encouragement to some organizations to simplify data collection and how it is reported. Special in-house solutions are developed by individual laboratories, while some enterprising companies are at the same time trying to develop more commercial reporting solutions in the form of specialized instrument-based systems.
In 1982, the first generation LIMS was introduced in the form of a single centralized minicomputer, which offered the lab a first chance to utilize automated reporting tools. Because interest in the early LIMS was growing, industry leaders such as Gerst Gibbon of the Federal Energy Technology Center in Pittsburgh began planting seeds through LIMS-related conferences. In 1988, second-generation commercial offerings made use of relational databases to expand LIMS into more specific areas for applications, and the International LIMS Conference went smoothly. When personal computers became more powerful and prominent, the third generation LIMS appeared in the early 1990s. The new LIMS utilizes client/server architecture, enabling the laboratory to implement better processing and data exchange.
In 1995 the client/server tool has evolved to allow for the processing of data anywhere on the network. Web-enabled LIMS was introduced the following year, enabling researchers to expand operations beyond laboratory boundaries. From 1996 to 2002 additional functions were included in LIMS, from wireless network capabilities and sample georeferencing, to the adoption of XML standards and the development of Internet purchases.
In 2012, some LIMS have added additional characteristics that continue to shape how LIMS is defined. Additions include clinical functions, notebook electronic laboratory functions (ELN), as well as improved software distribution models as services (SaaS).
Maps Laboratory information management system
Technology
Operation
The LIMS is a growing concept, with new features and functionality being added frequently. As laboratory demands change and technological advancements continue, the LIMS function is likely to change as well. Despite these changes, LIMS tends to have a set of basic functions that define them. The functionality can be divided into five phases of laboratory processing, with many software functions falling under each: (1) acceptance and entry of samples and related customer data; (2) assignment, scheduling, and sample tracking and related analytical workloads, (4) data storage related to sample analysis, (5) inspection, approval, and compilation of sample data for reporting and/or further analysis
There are several parts of the core functionality associated with these laboratory processing phases that tend to appear in most LIMS:
Sample management
The core function of LIMS is traditionally sample management. This usually begins when samples are received in the laboratory, at which point the sample will be listed in LIMS. Some LIMS will allow the customer to place an "order" for the sample directly to LIMS where the sample point is generated in an "unacceptable" state. Processing can then include the step in which the sample container is registered and sent to the customer for the sample to be retrieved and then returned to the lab. The registration process may involve accessing the sample and making the barcode to be attached to the sample container. Various other parameters such as clinical or phenotypic information corresponding to the sample are also frequently recorded. LIMS then tracks the chain of custody as well as the sample location. Location tracking usually involves assigning a sample to a particular freezer location, often to granular levels of shelves, shelves, boxes, rows, and columns. Other event tracking such as freezing and liquefaction cycles required for samples in the laboratory may be required.
Modern LIMS has implemented extensive configurability because every laboratory's need to track additional data points can vary widely. LIMS vendors usually can not make assumptions about what the data tracking needs are, and therefore vendors must create LIMS that can adapt to individual environments. LIMS users may also have regulatory issues to comply with such as CLIA, HIPAA, GLP, and FDA specifications, affecting certain aspects of sample management in LIMS solutions. One key to meeting many of these standards is the audit of all changes to LIMS data, and in some cases a complete electronic signature system is required for strictly tracking field-level changes to LIMS data.
Integration of instruments and apps
Modern LIMS offers increased amount of integration with laboratory instruments and applications. LIMS can create control files that are "inserted" into the instrument and direct its operations on some physical items such as sample tubes or sample plates. LIMS can then import the instrument result files to extract the data for the assessment of the quality control of the operation on the sample. Access to instrument data can sometimes be governed by the assignment of a chain of custody or other security features if required.
Modern LIMS products now also allow import and management of raw test data results. Modern targeted tests such as qPCR and sequencing can generate tens of thousands of data points per sample. Furthermore, in case of drug development and diagnostics as many as 12 or more tests can be run for each sample. To track this data, the LIMS solution must be able to adapt to different test formats in the data layer and import creation layer, while maintaining a high overall level of performance. Some LIMS products address this by simply attaching test data as Paralyzed to a sample, but this limits the usability of data in data mining and downstream analysis.
Electronic data exchange
The exponentially growing data volumes made in the laboratory, coupled with the increasing business demands and the focus on profitability, have encouraged LIMS vendors to increase attention on how their LIMS handles electronic data exchange. Attention should be given to how the instrument's input and output data are managed, how far sampled sample data is imported and exported, and how mobile technologies are integrated with LIMS. The successful transfer of data files in spreadsheets and other formats is an important aspect of modern LIMS. In fact, the transition "from the ownership database to a standardized database management system like MySQL" convincingly has one of the biggest impacts on how data is managed and exchanged in the laboratory. In addition to electronic and cellular data exchanges, many LIMS support real-time data exchange with Electronic Health Records used in core hospitals or clinical operations.
Additional functionality
Apart from the main functions of sample management, instrument and application integration, and electronic data exchange, there are many additional operations that can be managed within LIMS. These include but are not limited to:
- audit management
- fully track and maintain audit trail
- barcode handling
- assigns one or more data points to a barcode format; read and extract information from barcode
- chain track
- specifies the roles and groups that define access to a specific data record and who manages it
- compliance
- follow regulatory standards affecting labs
- customer relationship management
- handle demographic and communication information for related clients
- document management
- processes and converts data to a specific format; set how documents are distributed and accessed
- calibration and maintenance of instruments
- important maintenance schedules and calibration of laboratory instruments and keep detailed records of such activities
- inventory and equipment management
- measure and record inventory of vital supplies and laboratory equipment
- manual and electronic data entry
- provides a fast and reliable interface for data entered by human or electronic components
- management methods
- provides a location for all laboratory processes and procedures (P & amp; P) and methodologies to be placed and managed and connects each sample handling step with current instructions for performing operations
- personnel and workload management
- organize work schedules, workload tasks, employee demographic information, training, and financial information
- quality assurance and control
- measure and control sample quality, data entry standards, and workflow
- report
- create and schedule reports in a specific format; scheduling and distributing reports to designated parties
- time tracking
- calculate and maintain processing and handling time on chemical reactions, workflow, and more
- traceability
- shows audit trail and/or chain track of samples
- workflow
- track samples, sample batches, or "many" sets through its life cycle
Client-side options
LIMS has used many architectures and distribution models over the years. Because technology has changed, how a LIMS is installed, managed, and utilized has also changed with it. Here is an architecture that has been used at one point or another.
Thick-client
A thick client LIMS is a more traditional client/server architecture, with multiple systems residing on a user's computer or workstation (client) and the remainder on the server. LIMS software is installed on client computers, which perform all data processing. Then pass the information to the server, which has the main purpose of data storage. Most of the changes, improvements, and other modifications will occur on the client side.
This is one of the first architectures to be implemented into LIMS, having the advantage of providing higher processing speeds (because processing is done on clients and not servers). In addition, thick client systems also provide more interactivity and adjustment, though often on a larger learning curve. The client-side LIMS losses include the need for stronger client computers and more time-consuming upgrades, as well as lack of basic functionality through a web browser. A thick client LIMS can be web-enabled through an add-on component.
Although there are claims of increased security through the use of thick client LIMS, it is based on a misconception that "only users with client applications installed on their PC can access server-side information". This confidential design dependence is known as security through obscurity and ignores the opponent's ability to mimic client-server interaction through, for example, reverse engineering, network traffic interception, or simply buying thick client licenses. Such a view contradicts the "Open Design" principle of the National Institute of Standards and Technology Guidelines for Public Servers Security stating that "system security should not rely on the confidentiality of implementation or components", which may be regarded as a principle repetition Kerckhoffs.
Thin-client
A thin client LIMS is a more modern architecture that offers full application functionality accessed through a device's web browser. LIMS software is actually located on a server (host) that feeds and processes information without saving it to a user's hard disk. Any other changes, enhancements, and other modifications are handled by the entity hosting the server-side LIMS software, which means that all end users see all changes made. For this purpose, a true thin client LIMS will not leave a "trace" on the client computer, and only the integrity of the web browser needs to be maintained by the user. The benefits of this system include significantly lower cost of ownership and less network and client-side maintenance costs. However, this architecture has losses because it requires real-time server access, the need for increased network throughput, and less functionality. A hybrid architecture that combines the features of thin-client browsers with thick client installations is in the form of web-based LIMS.
Some LIMS vendors start hiring thin-client solutions that are hosted as "software as a service" (SaaS). These solutions tend to be less configurable than on-premises solutions and are therefore considered for less demanding implementations such as laboratories with few users and limited sample processing volumes.
Another implementation of thin client architecture is maintenance, warranty, and support (MSW) agreements. The price level is usually based on the percentage of licensing fees, with the standard service level for 10 concurrent users is about 10 hours of support and additional customer service, with about $ 200 per hour. Although some may choose to opt out of MSW after the first year, it is often more economical to continue the plan to receive updates to LIMS, thereby extending the life spans in the laboratory.
Web-enabled
The web-based LIMS architecture is basically a thick client-architecture with additional web browser components. In this setting, client-side software has additional functionality that allows users to interact with the software through their device's browser. This function is usually limited only to certain functions of the web client. The main advantage of web-based LIMS is that end users can access data both on the client side and server side configurations. As in the thick-client architecture, updates in the software must be disseminated to each client machine. However, additional losses that require always-access to the host server and the need for cross-platform functionality mean that additional overhead costs may arise.
Web-based
The web-based LIMS architecture is a combination of thick and thin client architectures. Although most client-side work is done through a web browser, LIMS may also require support for desktop software installed on client devices. The end result is a clear process for end users via a web browser, but it may not be so obvious because it runs processing like a thick client in the background. In this case, the web-based architecture has the advantage of providing more functionality through a more friendly web interface. The disadvantages of this arrangement are the more charred costs in system administration and reduced functionality on the mobile platform.
The disadvantages of thick clients are in the installation and application update stages. Users who want security, high speed, and thick client functionality can use Microsoft ClickOnce Technology. It allows users to install and run Windows-based smart client applications by clicking links on web pages. The software does not need to be installed in each user workstation one by one. The ClickOnce app can update itself; they can check for newer versions when they are available and automatically replace all the updated files.
Configurability
The implementation of LIMS is notorious for being long and expensive. This is due in part to the diversity of requirements in each lab, but also to the inflexibility of most LIMS products to adapt to these highly variable requirements. Newer LIMS solutions are starting to emerge that utilize modern techniques in software design that are inherently more configurable and adaptable - especially in the data layer - than the previous solution. This means not only a much faster implementation, but also lower cost and reduced risk of obsolescence.
Difference between LIMS and LIS
To date, LIMS and Laboratory Information Systems (LIS) have shown some key differences, making them into separate entities.
LIMS has traditionally been designed to process and report data related to a collection of samples from biological laboratories, water treatment facilities, drug trials, and other entities that handle complex data sets. LIS has been designed primarily to process and report data related to individual patients in a clinical setting.
A LIMS may need to fulfill good manufacturing practices (GMP) and meet the reporting and audit needs of regulatory agencies and research scientists in many different industries. However, LIS must meet the reporting and auditing needs of health care agencies, e.g. hospital accreditation agencies, HIPAA in the US, or other clinical medical practitioners.
A most competitive LIMS in a group-centric setting (dealing with "batches" and "samples") that often deal with most of the specialized research labs is anonymous, whereas LIS is typically most competitive in patient-centric settings (dealing with "subjects" and " specimen ") and clinical laboratory. LIS is set up as a medical device by the FDA, and the companies that produce the software are responsible for the defects. Because of this, LIS can not be customized by clients.
Standard
A LIMS includes standards such as 21 CFR Part 11 from the Food and Drug Administration (United States), ISO/IEC 17025, ISO 15189, good laboratory practice, and Good Automated Manufacturing Practice (GAMP).
See also
- Data management
- List of LIMS software packages
- Scientific management
- Title 21 CFR Part 11
- Virtual research environment
References
Further reading
- Gibbon, G.A. (1996). "LIMS short history" (PDF) . Automation and Information Management Laboratory . 32 (1): 1-5. doi: 10.1016/1381-141X (95) 00024-K.
Source of the article : Wikipedia
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